Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710117

FEI Number

3003349562

Entity Name

WATERTEC (MALAYSIA) SDN BHD

City/State/Country

Shah Alam Selangor, MY

Establishment Address

Lot 3 & 4, Jalan Halba Satu 16/16A, Section 16, Shah Alam Selangor 40200, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

WATERTEC (MALAYSIA) SDN BHD (Owner Number: 10042833)

Owner / Operator Contact Address

Lot 3, Jalan Halba Satu 16/16A, Section 16, Shah Alam, MY-10 40200, MY

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Transfer Board Sucker Foot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2013-01-04

Official Correspondent

Size Ong

US Agent Details

Paul Hanneman Email: paul.hanneman@performancehealth.com Phone: (630) 3936015

Related Public Records

Same Entity

WATERTEC (MALAYSIA) SDN BHD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710117. Last updated year: 2026. Please use registration number 9710117 when referencing this establishment in official correspondence.